The Medicines and Healthcare products Regulatory Agency (MHRA) issued a class 4 medicines defect information notice for zopiclone 3.75mg and 7.5mg tablets manufactured by Ratiopharm – whose parent company is Teva – and zopiclone 7.5mg tablets manufactured by Generics UK, trading as Mylan, last week (September 10).
The products from both brands are “missing important safety information related to potential suicide risks” from their patient information leaflets. This information is also missing from the summary of product characteristic for the Ratiopharm tablets, the MHRA alert said.
Healthcare professionals have been advised to make sure patients are “aware that the information on the possible risk of suicide is missing”.
If dispensing these products, pharmacists should make sure that patients are aware of the missing information and show the ma copy of the MHRA alert, the watchdog said.
According to the altert, some of the information missing in the patient information leaflets includes that: “Some studies have shown an increased risk of suicidal ideation, suicide attempt and suicide in patients taking certain sedatives and hypnotics, including this medicine [zopiclone].”
However, it also mentions that “it has not been established whether this is caused by the medicine or if there may be other reasons”.
Ratiopharm: Pharmacists welcome to ask questions
Ratiopharm is “aware of the issue” and is “working closely with the MHRA”, a spokesperson for its parent company Teva told C+D last week (September 11).
Teva “advocates that pharmacists read and follow the information in the alert”, the spokesperson said, stressing that patient safety is the company’s “top priority”.
Pharmacists are “welcome to contact” the company’s medical information team if they “have any questions”, they added.
Mylan: Product being discontinued
Mylan told C+D yesterday (September 16) that its zopiclone 3.75mg tablets are "in the process of being discontinued, were last sold in June 2020 and are no longer available for purchase”.
The health and safety of patients “is of utmost importance to us”, the spokesperson added, inviting pharmacists and patients with concerns about potential side effects to contact Mylan and speak to its medical information team.